Once-daily LCP-Tacro MeltDose tacrolimus for the prophylaxis of organ rejection in kidney and liver transplantations

被引:38
作者
Grinyo, Josep M. [1 ]
Petruzzelli, Stefano [2 ]
机构
[1] Univ Barcelona, Hosp Univ Bellvitge, Barcelona 08907, Spain
[2] Chiesi Farmaceut, Parma, Italy
关键词
efficacy; kidney transplantation; LCP-Tacro; liver transplantation; MeltDose((R)); once-daily administration; pharmacokinetics; prolonged-release formulation; safety; tacrolimus; TWICE-DAILY TACROLIMUS; RENAL-TRANSPLANTATION; CALCINEURIN INHIBITORS; PHASE-2; TRIAL; PHARMACOKINETICS; CONVERSION; CAPSULES; IMPACT; PHARMACOGENETICS; PHARMACODYNAMICS;
D O I
10.1586/1744666X.2014.983903
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Tacrolimus is a cornerstone of the immunosuppression regimen for prevention of allograft rejection in kidney and liver transplantations, with efficacy proven in many clinical trials. The currently available and extensively used tacrolimus formulations are flawed by large inter- and intra-individual variability, low bioavailability, wide peak-to-trough fluctuations and a narrow therapeutic index. Drug delivery technology can significantly impact the pharmacologic action of a drug, influencing its pharmacokinetic and subsequent therapeutic profile. LCP-Tacro is a novel, prolonged-release, MeltDose((R)) formulation of tacrolimus designed for once-daily administration. A hallmark differentiation between this formulation and other once- and twice-daily tacrolimus products is the proprietary MeltDose drug delivery technology which is designed to improve the bioavailability of drugs with low water solubility. Considering the studies conducted to date, once-daily LCP-Tacro has shown improved pharmacokinetic properties, rapid achievement of therapeutic trough levels, consistent exposure, non-inferior efficacy and similar safety, with lower tacrolimus dose than other tacrolimus formulations.
引用
收藏
页码:1567 / 1579
页数:13
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